preambles Archives

Preamble with backbone: “Universal” limits spinal-implant claims

The US Court of Appeals for the Federal Circuit affirmed summary judgment and a jury verdict of noninfringement, holding that claim preambles reciting a “universal” spinal implant were limiting and that substantial evidence supported the jury’s separate finding of noninfringement. Moskowitz Family LLC v. Globus Medical, Inc., Case No. 24-1696 (Fed. Cir. Sept. 11, 2026) (Prost, Schall, Stoll, JJ.)

Moskowitz sued Globus for infringing three patents directed generally to implant systems used in spinal-fusion surgery. The patents describe implant tools and intervertebral cages. For two of the asserted patents, the central dispute concerned the term “universal,” which appeared in the preambles of certain claims.

The district court construed the term “universal” as recited to mean “an intervertebral bone fusion spacer designed to be inserted between [vertebrae/vertebral bodies] in any region of the spine, i.e., cervical, thoracic, or lumbar, using any approach, e.g., posterior, anterior, or lateral.” Moskowitz conceded that the accused Globus products did not infringe under that construction but argued that the preambles were not limiting. The district court disagreed and granted summary judgment of noninfringement as to those patents. A jury later found that a claim of the third asserted patent was not infringed, and the district court denied Moskowitz’s motion for judgment as a matter of law (JMOL). Moskowitz appealed.

The Federal Circuit affirmed. As to the claims containing the “universal” language, the Court found the preambles limiting for two reasons. First, other terms in the body of the claims, such as “the intervertebral cage” and “the first integral screw guide,” relied on the preambles for antecedent basis. The Court explained that this dependence was a “strong indication that the preamble acts as a necessary component of the claimed invention.”

Second, the specifications confirmed that universality was a fundamental characteristic of the claimed inventions rather than merely an intended use. Without the preamble limitation, the claims would fail to capture that characteristic.

Moskowitz argued that “universal” should be separated from the remainder of the preamble, relying on cases in which the Federal Circuit treated different portions of a preamble differently. The Court rejected that argument, finding that “universal” was “intertwined with the remainder of the preambles” and did not merely recite an intended use. Even considered independently, universality remained a fundamental characteristic of the claimed invention, the Court explained.

The Federal Circuit also rejected Moskowitz’s argument that the district court’s construction improperly required a physically impossible “one-size-fits-all” implant. The Court explained that the patents instead described a design adaptable for use across different regions of the spine and with multiple surgical approaches. The construction did not require a single implant size or a single manner of insertion.

Turning to the patent that proceeded to trial, the Federal Circuit affirmed the denial of JMOL. The asserted claim required a gripper “cooperating with” a handle. Because neither party sought construction of “cooperating,” the jury was instructed to apply the term’s plain and ordinary meaning.

Globus’ expert testified regarding that ordinary meaning and explained why the accused products did not [...]

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When it Comes to Method of Use Claims, Preamble Language Regarding Intended Use is Limiting

The US Court of Appeals for the Federal Circuit issued three separate but related rulings (two precedential, one non-precedential) affirming decisions by the Patent Trial & Appeal Board (Board) regarding the validity of nine US patents and addressing the limitations of preamble language and motivation to combine. Eli Lilly Co. v. Teva Pharmaceuticals, Case Nos. 20-1876, -1877, -1878 (Fed. Cir. August 16, 2021) (Lourie, J.); Teva Pharmaceuticals v. Eli Lilly Co., Case Nos. 20-1747, -1748, -1750 (Fed. Cir. August 16, 2021) (Lourie, J.); Teva Pharmaceuticals v. Eli Lilly Co., Case Nos. 20-1749, -1751, -1752 (Fed. Cir. August 16, 2021) (Lourie, J.). These decisions come as the latest events in a dispute between Teva and Eli Lilly Company over competing products for the treatment of migraine headaches.

Teva owns nine patents directed to humanized antagonist antibodies that target calcitonin gene-related peptide. In 2018, the Food and Drug Administration (FDA) first approved Teva’s version of the biologic fremanezumab (Ajovy®) and then approved Lilly’s biologics license application for galcanezumab (Emgality®) eight days later. Both drugs are part of a new class of migraine therapeutic agents called calcitonin gene-related peptide antagonists.

Lilly challenged the validity of Teva’s nine patents covering Ajovy® in a series of inter partes review (IPR) petitions, arguing that the claims were obvious. The Board instituted IPR for all nine Teva patents. The similarity of subject matter and arguments led to three separate written opinions, each addressing three of the patents. In these decisions, the Board upheld the validity of three of the patents at issue (which covered methods of treating migraines with the antibodies) but found the claims of the six other patents directed to the antibodies themselves invalid.

Lilly appealed the first Board ruling covering methods of treating migraines to the Court. Lilly argued that the Board erred by (1) “reading a result into the constructions of the preambles and the term ‘effective amount,’” which led the Board to erroneously require Lilly to prove that a skilled artisan would have had “a reasonable expectation of achieving a result that was not claimed,” and (2) applying a too-high standard when weighing evidence to determine whether a skilled artisan would have a reasonable expectation of success. Lilly contended that a claim preamble containing only a statement of purpose cannot be a claim limitation and that no weight should have been given to the preambles. Teva argued that Lilly was basing its analysis on a false dichotomy between “limiting preambles” and preambles that are mere statements of purpose.

The Federal Circuit found the claim preambles to be limiting, reasoning that claims directed to methods of using compositions “are not directed to what the method ‘is’” but rather to “what the method ‘does,’” which usually is recited in the preamble. The preambles provided the only metric by which one practicing the claim could determine whether the amount administered is an “effective amount” and provided the antecedent basis for at least one later claim term in the independent claims.

After finding the preambles to [...]

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